{"id":2535,"date":"2020-05-16T09:37:46","date_gmt":"2020-05-16T07:37:46","guid":{"rendered":"https:\/\/q-finity.de\/?post_type=encyclopedia&#038;p=2535"},"modified":"2026-07-07T07:20:26","modified_gmt":"2026-07-07T05:20:26","slug":"computerized-system","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/","title":{"rendered":"Computerized System"},"content":{"rendered":"<p>The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together with the controlled functions and associated processes, trained people, qualified equipment and specifications and records.<\/p>\n<p>The computerized system is the regulated whole in the GAMP sense &ndash; and thus the object of validation: it is validated in its process context against its <a href=\"https:\/\/q-finity.de\/en\/glossar\/intended-use\/\" target=\"_self\" title=\"Intended Use is the purpose a system is meant to serve. That purpose comes from the business process, not from the technical system - which only has a function (fit for purpose). Intended Use defines what the overall system is validated against, and must not be confused with the system's function (the teleological trap).\" class=\"encyclopedia\">Intended Use<\/a>, while components are qualified or verified.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-2535","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Computerized System - Definition (GAMP 5) | QFINITY<\/title>\n<meta name=\"description\" content=\"A computerized system is the regulated whole: hardware, software, network, functions, processes, people and records; in GAMP terms the object of validation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Computerized System\" \/>\n<meta property=\"og:description\" content=\"A computerized system is the regulated whole: hardware, software, network, functions, processes, people and records; 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